Senior QC Microbiologist - Combination Products

United Therapeutics Corporation

20h • Onsite

About The Position

You're looking to be part of a brand new QC Microbiology team supporting all of our combination product programs. The Senior QC Microbiologist (Combination Products) maintains Quality Control microbiological systems for manufacturing facilities including air, water, and product testing per USP, EP and JP requirements where applicable. The Senior QC Microbiologist ensures the highest standards of quality and compliance within the QC microbiology laboratories. The Senior QC Microbiologist ensures timely and accurate testing, review, and release of materials, while maintaining rigorous quality and compliance standards to support production and R&D objectives.

Requirements

• Bachelor’s Degree in a scientific field, preferably microbiology or biology
• 5+ years of relevant experience in a microbiology laboratory
• Working knowledge of FDA, ICH, USP, EP and JP requirements with respect to microbiological activities
• Working knowledge of word processing, spreadsheets and email software
• Detail oriented, self-motivated, organized with the ability to prioritize work

Nice To Haves

• 3+ years of experience in pharmaceutical and GMP
• Working knowledge of LIMS, TrackWise, RAM, and MasterControl

Responsibilities

• Independently support manufacturing operations, including process validation, environmental monitoring, and sampling and testing of utility systems
• Perform microbiological testing on air, water, environmental, raw material, and finished product samples per UT SOPs and test methods
• Plan, prepare, and execute method validation protocols as required per USP, EP, and JP requirements
• Assist with establishing environmental and USP water system monitoring programs
• Lead investigations involving microbiology out-of-specification results
• Perform the procurement and qualification of new equipment
• Maintain and lead the laboratory 5S and inventory program, ensuring supplies are available and supporting budget forecasting
• Troubleshoot instrument problems and work with the lab manager and equipment technical services to resolve issues in a timely fashion
• Perform instrument maintenance and calibration verification or standardization as required
• Prepare, edit, and review SOPs and testing protocols
• Train and mentor new employees and perform peer reviews of documentation

Benefits

• Eligible employees may participate in the Company’s comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more.
• For additional information on Company benefits, please visit https://www.unither.com/careers/benefits-and-amenities

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level